NCT04311736: Exergames

Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults

Status unknown NA Last updated 17 March 2020

What this trial tests

NA trial testing Exergame in Mild Cognitive Impairment in 96 participants. Status unknown.

Timeline

1 October 2019

Primary endpoint
1 October 2021

1 October 2021

Quick facts

Lead sponsor	Moai Technologies LLC
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	96
Start date	1 October 2019
Primary completion	1 October 2021
Estimated completion	1 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Exergame
• Cycling
• Stretching

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Exercise Training — all drugs for Exercise Training →

Sponsor

Moai Technologies LLC

Who can join

65 and older, any sex, with Mild Cognitive Impairment or Exercise Training. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this research, a unique "Exergame" has been developed and is being tested. The Exergame consists of unique Virtual Reality Cognitive Training (VRCT) games combined with concurrent cycling on a recumbent stationary cycle. The Exergame seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized with cycling to promote cognition. Cycling through an interesting virtual environment will motivate and engage the older adult to participate in the exercise, and VRCT could augment cycling's effects on cognition. A further innovation is that the Exergame has been developed as both an Apple TV and iPAD application, making it widely accessible and available. It will provide a low-cost VRCT Exergame option that currently does not exist, one that is affordable and compatible with almost any stationary cycle. This project is significant because treatment that delays the onset of Alzheimer's Disease (AD) by five years could save the U.S. economy an estimated $89 billion by 2030 and no drugs can yet prevent, cure, or even slow AD. Aerobic exercise and cognitive training are two such promising interventions. Emerging mechanistic studies further suggest that the two interventions together may have a synergistic, superior cognitive effect than either intervention alone. The purpose of this project is to demonstrate the feasibility and efficacy of the Exergame intervention on cognition. An RCT is planned in which subjects are randomized on a 2:1:1 allocation ratio to 3 parallel groups (exergame:cycling only:attention control). Mixed methods will be used to assess outcomes in both phases.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: study protocol for randomized controlled trial of the Exergames Study.
   Salisbury D, Plocher T, Yu F. · · 2021 · cited 7× · PMID 33407727 · DOI 10.1186/s13063-020-04950-7
2. The Effects of Exergame Telerehabilitation in Persons With Subjective Cognitive Decline.
   Salisbury DL, Pituch KA, Yu F. · · 2024 · cited 5× · PMID 38486359 · DOI 10.1093/geront/gnae028